A Study of Hepalatide Combined With TAF and PEG-IFN as Finite Treatment of Chronic Hepatitis B Patients

NCT05244057 | Completed Phase 2

• 1 other identifier: L47-HB-FIN-1(New Finite)
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed to assess efficacy of a finitie treatment in Chronic Hepatitis B patients who had stable treatment of NAs for ≧ 2 years， which is compared hepalatide in combination with Pegylated Interferon + TAF with Pegylated Interferon +TAF. Subjects will be randomly assigned to the hepalatide or placebo groups , 15 subjects in each group . Subjects will receive hepalatide+Pegylated Interferon +TAF treatment for 48 weeks or placebo +PegylatedInterferon +TAF treatment for 48 weeks , Then, stopping hepalatide and Pegylate Interferon treatments and followed with further 8 weeks follow-up.

Conditions

Chronic Hepatitis B

Keywords

hepalatide, Hepatitis B，finite treatment,

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with negative conversion of HBsAg

  Proportion of subjects with negative conversion of HBsAg treatment at 8 weeks off treatment

  56 Weeks

Secondary Outcomes (5)

• Number of subjects with virological relapse(VR) at 8 weeks off treatment

  56 Weeks

• Number of subjects with clinical relapse(CR) at 8 weeks off treatment

  56 Weeks

• HBsAg is down from baseline at 8 weeks off treatment

  56 Weeks

• Number of subjects with Serological conversion of HBsAg

  56 Weeks

• Change in liver stiffness at 8 weeks off treatment

  56 Weeks

Study Arms (2)

Hepalatide + TAF + PEG-IFN

EXPERIMENTAL

Patients will receive 6.3mg Hepalatide +25mg Tenofovir alafenamide+ 90ug Pegylated Interferon for 48 weeks with a further follow-up period of 24 weeks.

Drug: Hepalatide; Drug: Tenofovir Alafenamide Tablets; Drug: Pegylated Interferon alfa 2a

Placebo+ TAF + PEG-IFN

PLACEBO COMPARATOR

Patients will receive Placebo +25mg Tenofovir alafenamide + 90ug Pegylated Interferon for 48 weeks with a further follow-up period of 24 weeks.

Drug: Placebo of Hepalatide; Drug: Tenofovir Alafenamide Tablets; Drug: Pegylated Interferon alfa 2a

Interventions

Hepalatide DRUG

6.3mg, s.c., qd for 48 weeks

Also known as: L47

Hepalatide + TAF + PEG-IFN

Placebo of Hepalatide DRUG

s.c., qd for 48 weeks

Also known as: Placebo

Placebo+ TAF + PEG-IFN

Tenofovir Alafenamide Tablets DRUG

25mg, p.o., qd for 48 weeks

Also known as: Vemlidy

Hepalatide + TAF + PEG-IFN; Placebo+ TAF + PEG-IFN

Pegylated Interferon alfa 2a DRUG

90ug, s.c., qw for 48 weeks

Also known as: Pegasys

Hepalatide + TAF + PEG-IFN; Placebo+ TAF + PEG-IFN

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. HBsAg or/and HBV DNA Positive for at least 6 months
• \. HBeAg negative
• \. Received NAs stabilization therapy for at least 2 years
• \. ALT≤ 2×ULN
• \. HBV DNA\< LLQD(lower limit of quantitative detection) in Screening
• \. Serum total bilirubin\<2×ULN
• \. no childbirth plan within 2 years and agree to take effective contraceptive measures throughout the treatment period and within 3 months after the last dose, and that the woman is not pregnant or breastfeeding.
• \. have not participant in another clinical trial within 3 months before screening
• \. Subjects have good compliance with the protocol
• \. Subjects understood and agreed to sign the informed consent form.

You may not qualify if:

• \. Contraindications of Peginterferon such as depressive disorder, epilepsy, autoimmune diseases, uncontrolled thyroid dysfunction, etc
• \. Subjects with cirrhosis, e.g., definite cirrhosis on imaging such as abdominal ultrasound and CT; liver biopsy with Metavir fibrosis score = 4; clinical diagnosis of cirrhosis by the investigator.
• \. Decompensated liver disease
• \. Child-Pugh score of B-C or over 6 points.
• \. Subjects with any of the following circumstances
• History of decompensated liver disease
• History of serious heart disease (including unstable or uncontrolled heart disease within 6 months)
• Uncontrolled seizures, severe psychiatric disorders, or a history of psychiatric disorders
• with history of organ transplantation
• with poorly controlled diabetes and hypertension
• with autoimmune diseases, immune-related extrahepatic manifestations, thyroid disease, malignant tumors, or in immunosuppressive therapy
• underlying diseases such as malignant tumor, severe infection, heart failure and chronic obstructive pulmonary disease and other serious diseases.
• with history of alcohol or drug abuse
• \. Creatinine clearance \<60 mL/min.
• \. HAV, HCV, HDV, HEV or HIV co-infection

Sponsors & Collaborators

• Shanghai HEP Pharmaceutical Co., Ltd.: lead
• Shanghai Tong Ren Hospital: collaborator
• Shanghai East Hospital: collaborator

Study Sites (1)

Shanghai Tong Ren Hospital

Shanghai, Shanghai Municipality, 200050, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

tenofovir alafenamide; peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Qin Zhang

  Shanghai Tong Ren Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 17, 2022
• Study Start: August 23, 2022
• Primary Completion: June 24, 2024
• Study Completion: June 24, 2024
• Last Updated: July 15, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)